Wide-Antral Pulmonary Vein Isolation in Atrial Fibrillation Ablation with a Single-shot Technique (WIDER-PVI) (WIDER-PVI)

November 18, 2024 updated by: Daniel Rodríguez Muñoz, Hospital Universitario 12 de Octubre

Wide-Antral Pulmonary Vein Isolation in Patients Undergoing Atrial Fibrillation Ablation with a Single-shot Technique: the WIDER-PVI Trial

The WIDER PVI study is a multicentre randomized clinical trial to compare the efficacy of antral versus extended antral PVI in patients with paroxysmal or persistent AF undergoing this procedure using a cryoablation balloon capable of 28 mm diameter (antral isolation) or 31 mm diameter (extended antral isolation) applications. The aim is to evaluate an objective of superiority of the extended antral isolation strategy versus antral isolation in the recurrence of atrial tachyarrhythmias at 1-year follow-up, both in episodes of >30 seconds duration and in overall arrhythmic load.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Ablation has become a first-line therapy in the rhythm control strategy for atrial fibrillation (AF).

Pulmonary vein electrical isolation (PVI) is the cornerstone of ablation therapy, based on its efficacy profile, safety and lack of alternatives.

Single shot techniques have been increasingly used as the initial approach for PVI, employing cryoablation, i.e. release of cryoenergy into the endocardium via an inflatable catheter, to achieve isolation.

The most commonly used diameter in cryoablation is 28 mm. These generate antral isolation whose profile depends on the distance between veins. When the application is made with larger devices, as has been observed with the cryoballoon with an expandable diameter of 31 mm or ablation devices using pulsed electric fields, the isolation is also antral at the level of the carina, making the result of PVI more similar to that obtained when ablation is performed with a Wide Antral Circumferential Ablation (WACA) strategy using point-to-point radiofrequency (the gold standard for PVI).

The WIDER-PVI study aims to answer the question of whether single-shot ablation with a 31 mm diameter device is superior to conventional ablation with a 28 mm diameter device. The answer to this question is relevant in the context of the development of new, larger devices and concerns about the impact of larger ablation on atrial function.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
440

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Italy
      • Brescia, Italy
        • Not yet recruiting
        • Poliambulanza Institute Hospital Foundation
      • Latina, Italy
        • Not yet recruiting
        • Ospedale Santa Maria Goretti
      • Maddaloni, Italy
        • Not yet recruiting
        • Clinica San Michele
      • Monza, Italy
        • Not yet recruiting
        • Fondazione IRCCS San Gerardo dei Tintori
      • Napoli, Italy
        • Not yet recruiting
        • Pellegrini Hospital
      • Padova, Italy
        • Not yet recruiting
        • Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova
      • Rome, Italy
        • Not yet recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS, University "Cattolica del Sacro Cuore"
      • Rome, Italy
        • Not yet recruiting
        • S. Pietro Fatebenefratelli Hospital
    • Isernia
      • Pozzilli, Isernia, Italy
        • Not yet recruiting
        • IRCCS Neuromed Mediterranean Neurological Institute
    • Napoli
      • Acerra, Napoli, Italy
        • Not yet recruiting
        • Casa di cura Villa dei Fiori
  • Spain
      • Bilbao, Spain
        • Not yet recruiting
        • HU Basurto
      • Granada, Spain
        • Not yet recruiting
        • HU Virgen de las Nieves
      • Huelva, Spain
        • Not yet recruiting
        • HU Juan Ramón Jiménez
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario 12 De Octubre
        • Contact:
          • Daniel Rodríguez Muñoz
      • Madrid, Spain
        • Not yet recruiting
        • HU Ramón y Cajal
      • Málaga, Spain
        • Not yet recruiting
        • HU Virgen de la Victoria
      • Sevilla, Spain
        • Not yet recruiting
        • HU Virgen Macarena

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age over 18 years old.
  • Previous diagnosis of paroxysmal or persistent atrial fibrillation less than 2 years after diagnosis.
  • Clinical indication to undergo a pulmonary vein isolation procedure using balloon cryoablation.

Exclusion Criteria:

  • Severe left atrial dilatation (indexed volume >48 ml/m2 or area >40 cm2 or indexed diameter >3.0 cm/m2).
  • Previous endocardial or surgical ablation of atrial fibrillation.
  • Severe frailty (Clinical Frailty Scale score 7 or higher) or life expectancy less than 1 year.
  • Inability to understand or give informed consent.
  • Performance of other left atrial ablations in addition to pulmonary veins.
  • Need to use another catheter in addition to the cryoablation catheter to complete pulmonary vein isolation.
  • Contraindication to anticoagulation or intolerance to heparin.
  • Presence of intra-atrial thrombus.
  • Reversible cause of atrial fibrillation.
  • Severe mitral or aortic valve disease.
  • Congenital heart disease.
  • Pregnancy or the prospect of pregnancy in the next 12 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Control strategy
Pulmonary vein isolation by 28 mm balloon cryoablation
Device: Cryoablation with cryoballoon 28 mm
Pulmonary vein isolation using 28 mm balloon cryoablation
Experimental: Experimental strategy
Pulmonary vein isolation by 31 mm balloon cryoablation
Device: Cryoablation with cryoballoon 31 mm
Pulmonary vein isolation using 31 mm balloon cryoablation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recurrence of atrial tachyarrhythmia
Time Frame: From enrollment to the end of follow up, assessed up to 12 months
Presence of atrial fibrillation, atrial flutter, atrial tachycardia in which the atrial rate exceeds 180 beats per minute, lasting more than 30 seconds after the blanking period (8 weeks) and without pharmacological anti-arrhythmic treatment during 12 months of follow-up with continuous ECG monitoring (in patients with continuous implantable monitor) or combined (in patients without implantable monitor), by optical heart rate monitoring combined with programmed intermittent ECG and in response to detection of heart rate irregularity).
From enrollment to the end of follow up, assessed up to 12 months
Arrhythmic load
Time Frame: From enrollment to the end of follow up, assessed up to 12 months
Percentage of time the patient has atrial tachyarrhythmia (atrial fibrillation, atrial flutter, atrial tachycardia in which the atrial rate exceeds 180 beats per minute) over the total monitored time.
From enrollment to the end of follow up, assessed up to 12 months
Arrhythmic load
Time Frame: From 0 up to 60 minutes for every atrial tacharrhythmia detected in each patient
Total duration of the longest episode of atrial tachyarrhythmia for each patient (cut off point: 60 minutes)
From 0 up to 60 minutes for every atrial tacharrhythmia detected in each patient

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Acute effectiveness
Time Frame: Every measure is assessed through procedure time, an average of 180 minutes
  • Percentage of veins in which complete occlusion (grade 4) is achieved pre-application
  • Percentage of veins requiring change to other than randomly assigned diameter
  • Percentage of patients in whom time to electrical isolation is visualised
  • Percentage of patients in whom pulmonary vein isolation is achieved at first application
  • Percentage of patients with termination of AF during applications, transitioning to sinus rhythm or to atrial tachycardia or flutter
Every measure is assessed through procedure time, an average of 180 minutes
Effectiveness in follow-up
Time Frame: Until the end of the study
  • Cardiovascular admissions
  • Visit to the emergency room for cardiovascular conditions
  • Death from any cause / death from cardiovascular cause
  • stroke/transient ischaemic attack
  • Percentage of patients requiring electrical or pharmacological cardioversion or new ablation for atrial tachyarrhythmia.
  • Percentage of patients with recurrence of AF after the blanking period and without pharmacological antiarrhythmic treatment.
  • Time to first recurrence of atrial tachyarrhythmia
  • Improvement in Atrial Fibrillation Effect on Quality of Life Questionnaire (AFEQT) score from visit 0 (pre-ablation) to follow-up visit 12 months after ablation.
Until the end of the study
Safety
Time Frame: Until the end of the study
  • Major (death, complication requiring surgical or interventional treatment (vascular, coronary, cardiac, others) or prolongation of hospital stay >48 hours, or complication with chronic sequelae or requiring chronic treatment for its management) and minor adverse events
  • Intra-procedural complication rate
Until the end of the study
Acute effectiveness
Time Frame: Every measure is assessed through procedure time, an average of 180 minutes
  • Total procedure duration
  • Left atrial dwell time
  • Radiation exposure (fluoroscopy time and dose-area product)
  • Time to pulmonary vein electrical isolation
Every measure is assessed through procedure time, an average of 180 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital Universitario 12 de Octubre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 5, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 20, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 20, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • WIDER-PVI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings